HUMAN PAPILLOMAVIRUS (HPV) DETECTION AND TYPING SYSTEM USING DNA CHIP ARRAYS TECHNIQUE

EQUIPMENT FOR DETECTION AND TYPING OF HUMAN PAPILLOMAVIRUS (HPV) USING DNA CHIP ARRAYS TECHNIQUE NUMBER OF EXAMINATIONS 100/year REAGENT TECHNICAL SPECIFICATIONS: Complete set of reagents, in packaging of at least 50 reactions, for the isolation and typing of HPV virus using the DNA Chip Arrays technique, allowing the identification of at least the following high and low-risk types of human papillomavirus (HPV): 6, 11, 16, 18, 26, 31, 33, 34, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 55, 56, 57, 58, 59, 68, 69, 70, 73, 82, 83, 84. Both the offered system and the reagents and chip arrays it uses must be suitable for in vitro diagnostic use (CE-IVD) in accordance with directive 98/79 EC. The kit must be complete, allow for the isolation, detection, and typing of viral DNA, and be accompanied by a complete system for reading and typing microarrays for the detection and determination of human papillomavirus (HPV). TECHNICAL SPECIFICATIONS: Microarray reading and typing system for the detection and determination of human papillomavirus (HPV) using the DNA CHIP ARRAYS technique. 1. The complete set of reagents must be accompanied by a complete system for reading and typing microarrays for the detection and determination of human papillomavirus (HPV). 2. It must include all necessary equipment required for hybridization and detection. 3. It must include all necessary reagents (Primers, dNTP/dUTP’s, TaqPolymerase, etc.) necessary for carrying out PCR. The method must be accompanied by Uracil to avoid contamination. 4. It must include all necessary reagents necessary for typing, according to the manufacturer's instructions. 5. It must allow the free use of any DNA recovery method from any manufacturer, without commitments or restrictions, and use a small amount of DNA. 6. The hybridization-detection process must be short and not exceed one hour. 7. The ChipArray must have all necessary quality control markers integrated, which must be quantified, analyzed, and displayed during the measurement process. The markers must check both the PCR product and the hybridization. 8. The typing method must be of high sensitivity and specificity and must fully meet the suitability criteria set by the World Health Organization (WHO). 9. It must allow typing of even a single sample, without the need to collect a minimum number of samples, without affecting operating costs. 10. It must be compatible and suitable for use with DNA samples from both human cervical swabs collected using the liquid-phase cytology method, and DNA samples from formalin-fixed and paraffin-embedded (FFPE) sections. 11. The operating system of the system must allow for the storage and archiving of samples, and their secure storage. It must also allow for the generation of color reports and their printing in PDF format. 12. Detailed user instructions, both for the analyzer and for the offered reagents, must be submitted, preferably in Greek. 13. To complete the examination, no materials other than those requested in the above table should be required. If additional materials (reagents and consumables) of exclusive supply are required, a detailed list of these must be submitted, and they must be offered at prices that are fixed for the entire duration of the contract in the financial offer.